MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00706195#VARIO TWIN, HL 20, 4-PUMPS

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted after new information has been received.

Event Description

It was reported that the hl 20 showed error message "art stop" while running the pump.Complaint #: (b)(4).

Manufacturer Narrative

It was reported that the hl 20 showed error message "art stop" while running the pump.The getinge technical support was in contact with the ssu (sales and service unit) in the support case#: 20477 to locate the issue and solve it.As stated by the ssu india the odu connector was dispatched and the part will be replaced.The permanent signal is at pin 1 of the odu connector.If an alarm is triggered, the signal at odu pin 1 is interrupted and the pump stops.The reported failure was also evaluated on 2020-12-01 by life cycle engineering as follows: this message is only displayed on the cardioplegia pump when the art pump is stopped.If it is also displayed although the art pump is running, a defect (cable break, pin bent,) at the odu of the art pump or a pump station of the hl20 can be the cause, because then the speed signal is not transmitted correctly.Thus the reported failure could be confirmed.The product in question was produced in 2016-06-23 the review of the non-conformities during the period of 2016-06-23 to 2020-12-03 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded.It is unknown when the event occurred, was the device being used for treatment.The hl20 in question was responsible for this complaint / event.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

(b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10776918
• MDR Text Key: 214345609
• Report Number: 8010762-2020-00372
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706195#VARIO TWIN, HL 20, 4-PUMPS
• Device Catalogue Number: 70104.3262
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1